EP1395324B1 - Catheter multilumiere servant a reduire l'ischemie des membres - Google Patents
Catheter multilumiere servant a reduire l'ischemie des membres Download PDFInfo
- Publication number
- EP1395324B1 EP1395324B1 EP01983207A EP01983207A EP1395324B1 EP 1395324 B1 EP1395324 B1 EP 1395324B1 EP 01983207 A EP01983207 A EP 01983207A EP 01983207 A EP01983207 A EP 01983207A EP 1395324 B1 EP1395324 B1 EP 1395324B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- catheter
- lumen
- patient
- distal end
- blood
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 201000002818 limb ischemia Diseases 0.000 title 1
- 210000004369 blood Anatomy 0.000 claims abstract description 51
- 239000008280 blood Substances 0.000 claims abstract description 51
- 230000010412 perfusion Effects 0.000 claims abstract description 21
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 15
- 210000005166 vasculature Anatomy 0.000 claims abstract description 12
- 230000017531 blood circulation Effects 0.000 claims abstract description 10
- 238000004891 communication Methods 0.000 claims description 16
- 239000012530 fluid Substances 0.000 claims description 16
- 238000003780 insertion Methods 0.000 claims description 10
- 230000037431 insertion Effects 0.000 claims description 10
- 230000002792 vascular Effects 0.000 claims description 9
- 238000005086 pumping Methods 0.000 claims description 7
- 230000002169 extracardiac Effects 0.000 claims description 5
- 239000003550 marker Substances 0.000 claims description 5
- 208000028867 ischemia Diseases 0.000 claims description 4
- 230000001502 supplementing effect Effects 0.000 claims description 2
- 230000002708 enhancing effect Effects 0.000 claims 3
- 238000011282 treatment Methods 0.000 abstract description 5
- 238000013461 design Methods 0.000 description 14
- 238000000034 method Methods 0.000 description 8
- 210000001519 tissue Anatomy 0.000 description 8
- 230000000694 effects Effects 0.000 description 4
- 210000003462 vein Anatomy 0.000 description 4
- 238000013459 approach Methods 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 238000011866 long-term treatment Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 230000002787 reinforcement Effects 0.000 description 2
- 239000004575 stone Substances 0.000 description 2
- 230000035899 viability Effects 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010007559 Cardiac failure congestive Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 210000002376 aorta thoracic Anatomy 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 210000000601 blood cell Anatomy 0.000 description 1
- 230000008081 blood perfusion Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000002615 epidermis Anatomy 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000012781 shape memory material Substances 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3613—Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3659—Cannulae pertaining to extracorporeal circulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/152—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel branching on and drawing blood from a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/857—Implantable blood tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
- A61M60/867—Devices for guiding or inserting pumps or pumping devices into the patient's body using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
Definitions
- the present invention relates to a multilumen catheter and, in particular, to multilumen catheters designed to prevent ischemia in patients when the catheter is positioned within the body.
- Some of the percutaneous procedures involve removing blood from the body and subsequently reluming it to the body.
- dialysis treatment involves first removing blood from the patient's circulatory system, treating the blood outside of the body, and then returning the blood to the patient's circulatory system to perfuse the various tissues and organs.
- cannulae with large carrying capacity may be necessary.
- By maximizing the cross-sectional area of the cannula the volume of blood that may be removed and/or returned to the patient's vascular system via the cannula is maximized.
- One approach to maximize the cross-sectional area of the cannula involves using either two single lumen catheters or a multi-luman catheter.
- one lumen would function to withdraw blood and one would function to return blood to the patient.
- One problem with using two single lumen catheters is that it subjects the patient to multiple percutaneous insertion procedures, which complicates the procedure and increases the potential for infection and other complications. Therefore, it would be desirable to have a catheter assembly which could be inserted into the patient through a single insertion site.
- Multilumen catheters in various forms have been employed for this purpose.
- multilumen catheters have been made with two, three or more lumens to serve various aspiration and infusion functions, including extracting and returning blood to vessels, taking blood samples for testing and providing medications to the patient's vascular system.
- Simple multilumen catheters have been made by providing two round catheters of equal or nearly equal length joined by a web, or thin strip. This approach is described in U.S. Patent No. 5,776,111 to Tesio .
- Other multilumen catheter designs have a unitary body with at least one septum dividing the lumens which extend from a proximal to a distal end.
- EP-A-0.711,574 describes catheters having round lumens arranged in side-by-side relationship and separated by a thin wall which enlarges into reinforcement zones to either end of the wall, the whole being contained within a generally elliptical outer surface.
- US-A-4,692,141 describes a double lumen catheter having an elongated tube with a proximal first cylindrical portion having an internal divider to define a pair of discrete lumens including a shorter lumen opening at approximately the distal end of the first cylindrical portion, and a longer lumen opening at the distal end of the elongated tube.
- the distal end of the tube has a smooth conical tapered tip that smoothly merges with the distal second cylindrical portion of the elongated tube.
- the lumens are "D" shaped in the first cylindrical portion.
- a plurality of outlet holes are provided in the vicinity of the conical tapered tip, and the shorter lumen opens at an aperture having a bevel.
- US-A-5,961,486 describes a multiple lumen catheter which connects between a vein of a patient and a blood treatment device. The catheter and the lumens thereof each define distal ends which are positioned within the vein.
- Blood is withdrawn from the vein through one of the lumens at a flow rate of at least about 200 ml./min. while also inserting blood into the vein through another of said lumens at a similar flow rate.
- the distal ends of the lumens are longitudinally spaced from each other by no more than about 5mm.
- multilumen catheters require only a single puncture of the epidermis, their performance is limited in at least two ways. For one, the outer perimeter of the multilumen catheter cannot exceed the inner diameter of the vessel into which it is inserted. Furthermore, the already limited cross-sectional area must be divided into at least two lumens, one for withdrawal and one for return. Thus the carrying capacity of each lumen is further reduced. To supply the same amount of blood, the velocity and pressure of the blood in the lumens must increase over what it would be in the vessel itself. This has the potential to cause damage to the vessel as blood comes jetting out of the return lumen. Also, it may put further stress upon blood cells, even causing hemolysis. Thus, multilumen catheters must be made as large as possible to carry enough blood at satisfactory conditions.
- the present invention provides a multilumen catheter for directing the flow of blood through a patient through a single cannulation site, said catheter comprising: a catheter having a proximal end, a first distal end and a second distal end; said first distal end extending distally further from the proximal end than the second distal end; a first lumen extending between said first distal end and said proximal end; and a second lumen extending between said second distal end and said proximal end, characterised in that said catheter comprises means for biasing said first distal end towards a J-shape so that said first lumen is curved at said first distal end such that blood exiting the lumen is directed back along the multilumen catheter.
- At least one aperture may be formed in one of the first or second lumens positioned near the proximal end so that the aperture permits active maintenance or enhancement of perfusion of blood to the patient's vasculature downstream of where the aperture resides in the vasculature when the catheter is inserted into the patient for treatment.
- the multilumen catheter further comprises a third lumen with distal and proximal ends configured to be positioned entirely within the patient's vascular system. This third lumen is configured to permit the passive flow of blood downstream of the catheter site to maintain or enhance perfusion.
- a connector formed in the shape of a Y (“Y-connector”) is positioned at the proximal end of the multilumen catheter.
- One leg of the Y-connector is in fluid communication with the first lumen and the other leg of the Y-connector is in fluid communication with the second lumen.
- an outflow conduit of a pumping system is fluidly engaged to one lumen of the multilumen catheter and an inflow conduit of the same system is fluidly engaged to the other lumen.
- the inflow and outflow conduits are fluidly coupled to a pump so that, when connected to the patient, the pump circulates blood from one distal end of the multilumen catheter to the other distal end, and also through at least one aperture in one of the first or second lumens positioned near the proximal end.
- the multilumen catheter of the present invention is incorporated into an extracardiac pumping system for supplementing blood circulation in a patient without any component thereof being connected to the patient's heart. Such a system is described in U.S. Patent No.
- the system includes, in addition to the multilumen catheter, a pump configured to pump blood through the patient at subcardiac rates, an inflow conduit fluidly coupled to the pump to divert blood to the pump from a first blood vessel, and an outflow conduit fluidly coupled to the pump to direct blood from the pump to a second blood vessel.
- the method comprises the step of inserting the multilumen catheter described above into the patient at a single cannulation site of a first blood vessel, locating the catheter such that a first lumen may be in fluid communication with a second blood vessel and a second lumen may be in fluid communication with the first blood vessel, withdrawing blood from one of said blood vessels through one of the first or said second lumens, and delivering blood through the other of said first or second lumens so that blood is delivered upstream and downstream of the cannulation site.
- the multilumen catheter preferably is of unitary construction and requires only one entry point into the patient's body.
- the multilumen catheter 10 comprises at least two lumens: a first lumen 12 and a second lumen 14.
- the first lumen 12 extends from a proximal end 16 of the multilumen catheter 10 to a first distal end 18.
- the second lumen 14 extends from the proximal end 16 of the multilumen catheter 10 to a second distal end 20.
- the lumens 12, 14 of the multilumen catheter 10 may be arranged in one of many different ways.
- the two lumens may be joined in a side-by-side manner, forming a "figure-8" when viewed from the proximal end 16.
- a single cylindrical catheter housing may contain within it two or more side-by-side lumens.
- a cylindrical catheter housing could be formed with a diametral septum, i.e. a wall, extending across the cylinder at a diameter.
- a cylindrical housing with concentrically positioned lumens is also contemplated.
- the first distal end 18 may be formed with one or more distal apertures 22, although such apertures may also be located in the second distal end 20.
- the distal apertures 22 may be positioned close together or spaced circumferentially around the distal end.
- the apertures 22 serve to decrease the pressure drop across the cannula tip, thereby minimizing damage to vessel walls from jetting effects. It may also be appropriate to practice methods for directing blood flow so as to minimize damage to vessel walls from jetting effects and from the recoil effect on the catheter of blood exiting a catheter.
- the catheter 10 may further comprise a tapered tip 24 at the first distal end 18, which facilitates insertion and threading of the catheter into the patient.
- the catheter 10 may also further comprise a tapered tip 26 at the second distal end 20.
- One preferred design of the multilumen catheter further comprises a set of apertures 28 positioned on the catheter 10 near the proximal end 16.
- the apertures 28 are formed on at least one lumen of the catheter to provide for fluid communication between one of the lumens 12, or 14 of the multilumen catheter 10 and the blood vessel in which it resides.
- a radiopaque marker 30 may be positioned at the distal end 18 of the multilumen catheter 10.
- the multilumen catheter could further comprise markings 32 near the proximal end of the multilumen catheter which are a known distance from one or more of the distal ends. These markings 32, as well as the marker 30 can be used to accurately position the catheter when applied to the patient
- the multilumen catheter 110 comprises a third lumen 134 extending between a proximal end 136 and a distal end 138.
- the lumen 134 is positioned and sized such that when the multilumen catheter 110 is applied to the patient (described below), the lumen resides entirely within the patient's body.
- the lumen 134 may be connected to the catheter 110 in a variety of ways.
- the purpose of the third lumen 134 is to pemit the passive flow of blood downstream to the catheter to enhance perfusion.
- the design - shown in Figure 2 also may have apertures 128 disposed near the proximal end 116 of the multilumen catheter 110.
- this design may further comprise a tapered tip 140 at the distal end of the third lumen 134 and a tapered tip 142 at the proximal end of the third lumen 134 to facilitate application of the catheter to the patient.
- the third lumen 134 may be made of collapsible material. In the collapsed state, the third lumen 134 would conform to at least a portion of the outside surface of the multilumen catheter 110. Once applied to the patient, as described in more detail below, the lumen 134 would be expanded to the deployed state shown in Figure 2 .
- This collapsible lumen could comprise a stone basket, or a frame similar to a stent
- a stone basket is a structure that can be deployed within a patient's body and is used to capture objects. Here, the basket is used primarily to create a space between the catheter 110 and the vessel wall to permit the passive flow of blood downstream of the catheter site to enhance perfusion.
- the first distal end 218 is formed in the shape of a J-tip. That is, the opening at the distal end 218 may be curved such that blood exiting the lumen 212 is directed back along the multilumen catheter 210. Distal aperture(s) 222 may be formed at the bend of the J-tip so that blood also exits the lumen 212 and flows distal of the catheter 210.
- the "J" shape of the multi-lumen catheter tip may be formed and/or maintained by pre-loading it with a coil or with wire reinforcement, or by using a shape-memory material to create and maintain this shape. If the catheter is inserted so that the tip is straight and the "J" shape is deployed after the catheter inserted into the patient, the catheter may comprise a tapered tip at the first distal end 218, as described above.
- multilumen catheter 310 comprising a Y-connector 334 formed at the proximal end of the multilumen catheter 310.
- the lumens are separated in any suitable way such that fluid communication is provided between the distal end 318 of the lumen 312 of the multilumen catheter 310 and the proximal end 336 of one leg of the Y-connector 334, and fluid communication is provided between the distal end 320 of the lumen 314 of the catheter 310 and the proximal end 338 of one leg of the Y-connector 334.
- any of the multilumen catheters described herein may be made from various materials to improve their viability in long-term treatment applications.
- the biocompatibility of the catheter be improved compared to uncoated catheters to prevent adverse reactions such as compliment activation and the like.
- the interior lumens of the catheters can be coated with biocompatible materials.
- anti-bacterial coatings are also known in the art. Such coatings may be very useful on the outer surface of the catheter. This is especially true at or about where the catheter enters the patient's skin. At such a location, the patient is vulnerable to introduction of bacteria into the body cavity. Anti-bacterial coatings can reduce the likelihood of infection and thus improve the viability of long-term treatments.
- the multilumen catheter of the present invention may be integrated into a pumping system, such as the one described in more detail in U.S. Patent No. 6,200,260 .
- a pumping system such as the one described in more detail in U.S. Patent No. 6,200,260 .
- a system comprises the multilumen catheter 10, an inflow conduit 38, an outflow conduit 40 and a pump 42.
- One end of the outflow conduit 40 may be connected to the proximal end of the lumen 12, while the other end is connected to the inlet of the pump 42.
- One end of the inflow conduit 38 may be connected to the proximal end of the lumen 14, while the other end is connected to the outlet of the pump 42. This results in a flow from the first distal end 18 to the second distal end 20.
- the flow direction may be reversed using the same multilumen catheter, resulting in a flow from distal end 20 to distal end 18.
- the outflow conduit 40 is connected to the proximal end of lumen 14 and the inflow conduit 38 is connected to the proximal end of lumen 12.
- the present multilumen catheter 10 when incorporated into a pumping system may be applied to a patient in an arterial-arterial fashion. Where the multilumen catheter 10 is inserted into the femoral artery 44 of the patient 46.
- the radiopaque marker 30 which may be incorporated into the distal end 18 of the multilumen catheter is used to track the insertion of the catheter so that the catheter may be positioned at a desired site within the patient's vascular system. As mentioned above, markings 32 on the proximal end could also be used to locate the distal end or ends.
- the distal end 18 may be located in the aortic arch 48.
- the pump draws blood from the patient's vascular system in the area near the distal end 18 and into the lumen 12. This blood is further drawn into the lumen of the conduit 40 and into the pump 42. The pump 42 then expels the blood into the lumen of the outflow conduit 38.
- This lumen carries the blood into the lumen 14 of the multilumen catheter 10 and back into the patient's vascular system in the area near the distal end 20.
- the apertures 28 and/or the third lumen 134 provide blood flow to the patient's vasculature downstream of where the multilumen catheter resides in the vasculature to maintain or enhance perfusion of blood.
- the blood flow in the multilumen catheter may be reversed. In that case, blood is drawn from the patient through distal end 20 and returned to the patient through distal end 18.
- the multilumen catheter 10 comprises features that will maintain or increase the blood flow to downstream tissue when the catheter is inserted into the patient.
- the apertures 28 provide for fluid communication between at least one lumen 12 or 14 and the patient's blood vessel. The apertures 28, thus, provides active perfusion of the downstream tissues.
- the lumen 134 of the design shown in Figure 2 is located entirely within the vessel when the catheter 110 is inserted into the patient.
- the lumen provides a pathway for blood flow to tissue downstream of the catheter so that the catheter 110 may maintain or increase the flow of blood to downstream tissue.
- the lumen 134 thus, provides passive perfusion. If desired, apertures may be included in one of the other two lumens to supplement passive perfusion with active perfusion.
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Mechanical Engineering (AREA)
- External Artificial Organs (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Surgical Instruments (AREA)
Claims (23)
- Cathéter multilumière destiné à diriger le flux sanguin chez un patient à travers un site de canulation unique, ledit cathéter comprenant :un cathéter (210) présentant une extrémité proximale (216), une première extrémité distale (218) et une deuxième extrémité distale (220), ladite première extrémité distale (218) s'étendant de manière distale plus loin de l'extrémité proximale (216) que la deuxième extrémité distale (220) ;une première lumière (212) s'étendant entre ladite première extrémité distale (218) et ladite extrémité proximale (216) ; etune deuxième lumière (214) s'étendant entre ladite deuxième extrémité distale (220) et ladite extrémité proximale (216), caractérisé en ce que ledit cathéter comprend un moyen destiné à solliciter ladite première extrémité distale (218) vers une forme en J de sorte que ladite première lumière (212) est incurvée au niveau de ladite première extrémité distale (218) de sorte que le sang sortant de la lumière (212) est redirigé le long du cathéter multilumière (210).
- Cathéter multilumière selon la revendication 1, comprenant en outre un moyen destiné à maintenir ou renforcer une perfusion sur le système vasculaire du patient et à minimiser une ischémie en aval d'un point d'entrée dudit cathéter dans un vaisseau sanguin lorsque ledit cathéter est inséré dans le patient.
- Cathéter multilumière selon la revendication 2, dans lequel le moyen destiné à maintenir ou renforcer une perfusion comprend un moyen de perfusion actif.
- Cathéter multilumière selon la revendication 3, dans lequel le moyen de perfusion actif comprend une ouverture (222, 226).
- Cathéter multilumière selon la revendication 3, dans lequel le moyen de perfusion actif est au moins une ouverture (226) dans l'une desdites lumières (212, 214) positionnées près de l'extrémité proximale (216).
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel le moyen destiné à maintenir ou renforcer une perfusion comprend un moyen de perfusion passif.
- Cathéter multilumière selon la revendication 6, dans lequel le moyen de perfusion passif est une troisième lumière présentant une extrémité distale et une extrémité proximale configurées pour être positionnées entièrement au sein du système vasculaire du patient.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, comprenant en outre un connecteur en Y positionné au niveau de l'extrémité proximale, où une première jambe du connecteur en Y est en communication de fluide avec ladite première lumière et une deuxième jambe dudit connecteur en Y est en communication de fluide avec ladite deuxième lumière.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, comprenant en outre un conduit de sortie engagé de manière fluide sur une première lumière et un conduit d'entrée engagé de manière fluide sur l'autre lumière, lesdits conduits d'entrée et de sortie étant couplés de manière fluide à une pompe de sorte que, lorsqu'ils sont connectés à un patient, ladite pompe fait circuler le sang d'une première extrémité distale dudit cathéter multilumière à l'autre extrémité distale et également à travers au moins une ouverture.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel la première extrémité distale est inclinée.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel la deuxième extrémité distale est inclinée.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel l'une desdites extrémités distales comprend au moins une ouverture distale.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel ladite première extrémité distale (218) comprend un bout en J comportant un coude.
- Cathéter multilumière selon la revendication 13, dans lequel ledit bout en J comprend une ouverture (222) positionnée au niveau de la partie la plus distale du coude.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, comprenant en outre un marqueur radio-opaque (230), où le marqueur radio-opaque (230) peut être utilisé pour positionner le cathéter lorsque le cathéter est appliqué à un patient.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, comprenant en outre un indicateur (232) près de l'extrémité proximale (216), où l'indicateur (232) peut être utilisé pour positionner le cathéter lorsque le cathéter est appliqué à un patient.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel l'extrémité proximale (216) comporte deux orifices.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel le cathéter est conçu pour une insertion dans un patient, le cathéter ayant une périphérie continue au niveau du site de sortie de la peau du patient.
- Cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel ladite première lumière (212) est incurvée au niveau de ladite première extrémité distale (218) après que le cathéter est inséré dans le patient.
- Cathéter multilumière selon l'une quelconque des revendications 1 à 18, dans lequel ladite première lumière (212) est incurvée au niveau de ladite première extrémité distale (218) avant que le cathéter ne soit inséré dans le patient.
- Système de pompage extracardiaque destiné à compléter la circulation sanguine chez un patient sans qu'aucun de ses composants ne soit connecté au coeur du patient, le système extracardiaque comprenant :une pompe configurée pour pomper du sang dans le patient à des débits inférieurs au débit cardiaque, ladite pompe ayant un débit moyen qui, au cours de son fonctionnement normal, est sensiblement inférieur à celui du coeur du patient lorsqu'il est sain ;un conduit d'entrée relié de manière fluide à la pompe pour diriger le sang vers la pompe à partir d'un premier vaisseau sanguin ;un conduit de sortie relié de manière fluide à la pompe pour diriger le sang de la pompe vers un deuxième vaisseau sanguin ; etle cathéter multilumière selon l'une quelconque des revendications précédentes, dans lequel la première lumière de celui-ci est en communication de fluide avec un premier conduit parmi ledit conduit d'entrée et ledit conduit de sortie et la seconde lumière de celui-ci est en communication de fluide avec l'autre conduit parmi ledit conduit d'entrée et ledit conduit de sortie.
- Système de pompage extracardiaque selon la revendication 21, dans lequel ladite première lumière est en communication de fluide avec ledit conduit de sortie et ladite deuxième lumière est en communication de fluide avec ledit conduit d'entrée.
- Système de pompage extracardiaque selon la revendication 21, dans lequel ladite première lumière est en communication de fluide avec ledit conduit d'entrée et ladite deuxième lumière est en communication de fluide avec ledit conduit de sortie.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/876,281 US7048680B2 (en) | 2001-06-06 | 2001-06-06 | Multilumen catheter for minimizing limb ischemia |
| US876281 | 2001-06-06 | ||
| PCT/US2001/042774 WO2002098499A2 (fr) | 2001-06-06 | 2001-10-15 | Catheter multilumiere servant a reduire l'ischemie des membres |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP1395324A2 EP1395324A2 (fr) | 2004-03-10 |
| EP1395324B1 true EP1395324B1 (fr) | 2008-07-09 |
Family
ID=25367348
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP01983207A Expired - Lifetime EP1395324B1 (fr) | 2001-06-06 | 2001-10-15 | Catheter multilumiere servant a reduire l'ischemie des membres |
Country Status (9)
| Country | Link |
|---|---|
| US (4) | US7048680B2 (fr) |
| EP (1) | EP1395324B1 (fr) |
| JP (1) | JP2004528139A (fr) |
| AT (1) | ATE400314T1 (fr) |
| AU (1) | AU2002214653C1 (fr) |
| CA (1) | CA2449689A1 (fr) |
| DE (1) | DE60134790D1 (fr) |
| ES (1) | ES2307661T3 (fr) |
| WO (1) | WO2002098499A2 (fr) |
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| US6719749B1 (en) * | 2000-06-01 | 2004-04-13 | Medical Components, Inc. | Multilumen catheter assembly and methods for making and inserting the same |
| US6488662B2 (en) | 2000-12-19 | 2002-12-03 | Laksen Sirimanne | Percutaneous catheter assembly |
| US6761700B2 (en) | 2001-02-09 | 2004-07-13 | Orqis Medical Corporation | Extra-corporeal vascular conduit |
| US7048680B2 (en) * | 2001-06-06 | 2006-05-23 | Orqis Medical Corporation | Multilumen catheter for minimizing limb ischemia |
| US20020188167A1 (en) * | 2001-06-06 | 2002-12-12 | Anthony Viole | Multilumen catheter for minimizing limb ischemia |
| US20050085683A1 (en) * | 2003-10-15 | 2005-04-21 | Bolling Steven F. | Implantable heart assist system and method of applying same |
| US20050113631A1 (en) * | 2003-11-12 | 2005-05-26 | Bolling Steven F. | Cannulae having a redirecting tip |
| US20050131385A1 (en) * | 2003-12-12 | 2005-06-16 | Bolling Steven F. | Cannulae for selectively enhancing blood flow |
| US7445592B2 (en) * | 2004-06-10 | 2008-11-04 | Orqis Medical Corporation | Cannulae having reduced flow resistance |
| US20050277804A1 (en) * | 2004-06-10 | 2005-12-15 | Robert Pecor | System including a cannula having reduced flow resistance |
-
2001
- 2001-06-06 US US09/876,281 patent/US7048680B2/en not_active Expired - Lifetime
- 2001-10-15 EP EP01983207A patent/EP1395324B1/fr not_active Expired - Lifetime
- 2001-10-15 AT AT01983207T patent/ATE400314T1/de not_active IP Right Cessation
- 2001-10-15 DE DE60134790T patent/DE60134790D1/de not_active Expired - Lifetime
- 2001-10-15 CA CA002449689A patent/CA2449689A1/fr not_active Abandoned
- 2001-10-15 JP JP2003501535A patent/JP2004528139A/ja active Pending
- 2001-10-15 ES ES01983207T patent/ES2307661T3/es not_active Expired - Lifetime
- 2001-10-15 AU AU2002214653A patent/AU2002214653C1/en not_active Ceased
- 2001-10-15 WO PCT/US2001/042774 patent/WO2002098499A2/fr not_active Ceased
-
2003
- 2003-12-22 US US10/743,841 patent/US20040138519A1/en not_active Abandoned
-
2006
- 2006-05-03 US US11/417,509 patent/US20060270891A1/en not_active Abandoned
- 2006-05-03 US US11/418,499 patent/US20060270895A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| ATE400314T1 (de) | 2008-07-15 |
| US20020188166A1 (en) | 2002-12-12 |
| US20040138519A1 (en) | 2004-07-15 |
| AU2002214653B2 (en) | 2006-04-13 |
| US7048680B2 (en) | 2006-05-23 |
| DE60134790D1 (de) | 2008-08-21 |
| ES2307661T3 (es) | 2008-12-01 |
| WO2002098499A3 (fr) | 2003-07-24 |
| WO2002098499A2 (fr) | 2002-12-12 |
| US20060270891A1 (en) | 2006-11-30 |
| US20060270895A1 (en) | 2006-11-30 |
| EP1395324A2 (fr) | 2004-03-10 |
| CA2449689A1 (fr) | 2002-12-12 |
| AU2002214653C1 (en) | 2006-12-14 |
| JP2004528139A (ja) | 2004-09-16 |
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